Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

In December 2017, ertugliflozin (Steglatro™), developed by Merck and Pfizer, received its first global approval in the US for use in conjunction with exercise and diet to improve glycaemic control in adults with type-2 diabetes mellitus (T2DM). [1 Continue reading “Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus”

Using state-of-the-art technology to combat challenges unique to 21st century culture

Using state-of-the-art technology to combat challenges unique to 21st century culture

Since I now have a piqued interest in the application of artificial intelligence in pharmacovigilance, I was interested to read the findings from a study using machine learning to identify ICSRs in social media.  Until now, my impression of ADRs reported in the social media was that identifying valid ICSRs was more than challenging due to their diversity, complexity, colloquialisms and anonymity. Also, it seems the regulatory authorities acknowledge these challenges as it is not yet a regulatory requirement to monitor social media as a source for ICSRs. But is this looking set to change if machine learning and automation become the norm? Continue reading “Using state-of-the-art technology to combat challenges unique to 21st century culture”

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

In February 2018, durvalumab (IMFENZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1] Continue reading “Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA”